| CTRI Number |
CTRI/2021/03/032045 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cannulation of subclavian vein in adult patients under ultrasound guidance : comparison of two approaches- above the collar bone approach with below the collar bone approach |
|
Scientific Title of Study
|
ULTRASOUND GUIDED SUBCLAVIAN VEIN CATHETERIZATION: COMPARISON OF SUPRACLAVICULAR WITH INFRACLAVICULAR APPROACH IN ADULT SURGICAL PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Jaiswal |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of anaesthesia, Main OT block, VMMC And Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9260940904 |
| Fax |
|
| Email |
jaiswalpooja11392@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of anaesthesia, Main OT block, VMMC And Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of anaesthesia, Main OT block, VMMC And Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of anaesthesia, Main OT block, VMMC And Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Jaiswal |
VMMC And Safdarjung Hospital |
Main OT block, Department of Anaesthesia, VMMC And Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI |
9260940904
jaiswalpooja11392@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/VMMC/SJH/Thesis/2020-11/CC-39 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z452||Encounter for adjustment and management of vascular access device. Ayurveda Condition: NANATMAJAPITTAVIKARAH, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ultrasound guided Subclavian Vein catherization: Comparison of supraclavicular with infraclavicular approach in adult surgical patients |
To compare supraclavicular and infraclavicular approaches of ultrasound guided subclavian vein catheterization in terms of ease of catheterization in adult patients undergoing elective surgeries using total procedural time. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex from 18-65 years of age belonging to American Society of Anaesthesiologists (ASA) grade I or II scheduled to undergo elective surgeries under general anaesthesia and requiring CVC insertion. |
|
| ExclusionCriteria |
| Details |
1. Distorted anatomy of chest, neck, clavicle and any congenital vascular anomaly in neck
2. Contraindications to the CVC insertion (Coagulopathies, on anticoagulants, local site infection)
3. Patients with hypovolemic or septic shock
4. Emergency surgery
5. Prior pneumothorax
6. Patients with raised intracranial pressure
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare supraclavicular and infraclavicular approaches of ultrasound guided subclavian vein catheterization in terms of ease of catheterization in adult patients undergoing elective surgeries using total procedural time. |
At the initiation of the procedure till the end of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to visualisation of subclavian vein
2. Diameter of subclavian vein
3. Puncture time
4. Number of attempts
5. Success rate
6. Complication rate |
At the initiation of the procedure and after the procedure, X ray is done to rule out procedure related complications. ( post procedure X ray) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised comparative interventional study comparing the supraclavicular approach with the infraclavicular approach of ultrasound guided subclavian vein catheterization in terms of ease of catheterization in 60 adult patients undergoing elective surgeries using total procedural time as primary outcome. The two approaches will be compared in terms of total procedural time, time to visualisation of subclavian vein( using ultrasound), diameter of subclavian vein, puncture time, number of attempts, success rate and complication rate of each approach. A post procedure X ray will be done to rule out complications associated with the procedure. |